Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102
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Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102

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Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102 PR Newswire TOKYO, May 31, 2012 TOKYO, May 31, 2012 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.

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Taiho Pharmaceutical Announces Start of
Global Phase III Clinical Trial in Metastatic
Colorectal Cancer with Novel Antitumor Agent
TAS-102
PR Newswire
TOKYO, May 31, 2012
TOKYO
,
May 31, 2012
/PRNewswire/ -- Taiho Pharmaceutical Co., Ltd.
announced on
May 31
that a global Phase III clinical trial (RECOURSE) for the
novel combination antimetabolite TAS-102 will start in June this year.
RECOURSE is a randomized, double-blind, placebo-controlled Phase III trial that
compares TAS-102 with best supportive care (BSC) to investigate the efficacy
and safety of TAS-102 when administered to patients with advanced recurrent
colorectal cancer that is both unresectable and relapsed/refractory to standard
chemotherapies. Standard chemotherapies include fluoropyrimidines,
irinotecan, oxaliplatin, bevacizumab and, in the case of patients whose tumor
harbors the wild-type KRAS gene, an anti-EGFR monoclonal antibody. The
primary endpoint is overall survival. Eight hundred patients around the world
will be enrolled into the trial, beginning in
Japan
in June, followed by
North
America
,
Europe
and
Australia
. The principal investigators will be Dr. Atsushi
Ohtsu, National Cancer Center Hospital East (Kashiwa/
Japan
), Dr. Robert J.
Mayer, Dana Farber Cancer Institute (
Boston
/
USA
), and Dr. Eric Van Cutsem,
University Hospital Gasthuisberg (Leuven/
Belgium
).
Taiho Pharmaceutical is proceeding with the global development of TAS-102 so
that this drug can be offered as soon as possible to metastatic colorectal
cancer patients who have exhausted standard treatment options.
About TAS-102
TAS-102 combines: FTD (alpha, alpha, alpha-trifluorothymidine), a nucleoside
analog which disrupts a variety of DNA functions necessary for the proliferation
of cancer cells by being efficiently incorporated into DNA, and 5-chloro-6-(2-
iminopyrrolidin-1-yl)-methyl-2, 4(1H, 3H)-pyrimidinedione hydrochloride (TPI),
which maintains an effective blood concentration of FTD by inhibiting thymidine
phosphorylase which is the primary enzyme involved in the degradation of FTD.
See the
July 22, 2011
News Release for details on the Phase II clinical trial.
In Japanese: http://www.taiho.co.jp/corporation/news/2011/20110722.html
In English: http://www.taiho.co.jp/english/news/20110722.html
About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-
driven specialty pharma focusing on the three fields of oncology, allergies and
immunology, and urology. Its corporate philosophy takes the form of a pledge:
"We strive to improve human health and contribute to the enrichment of
society." In the field of oncology in particular, Taiho Pharmaceutical is known as
a leading company in
Japan
and around the world for developing evidence-
based medicines for the treatment of cancer. In areas other than oncology as
well, the company creates quality products that effectively treat medical
conditions and can help improve people's quality of life. Always putting
customers first, Taiho Pharmaceutical also aims to offer over-the-counter
medicinal products that support people's efforts to lead fulfilling and rewarding
lives. The company is headquartered in
Tokyo
and its President is Masayuki
Kobayashi. For more information about Taiho Pharmaceutical, please visit
http://www.taiho.co.jp/english/
About Otsuka Holdings Co., Ltd.
The Otsuka Group is a diversified healthcare group operating globally under the
corporate philosophy "Otsuka-people creating new products for better health
worldwide". The Otsuka Group has business operations in 24 countries and
regions around the world, and its consolidated sales for FY2011 are
1,154.6
billion Japanese yen
. For more information, please visit the company's website
at www.otsuka.com/en/.
Contact:
Mitsutoshi Utatsu
Public Relations Dept.
Taiho Pharmaceutical Co., Ltd.
Tel: +81-3-3293-2878
e-mail: th-102a@taiho.co.jp
* For inquiries, please contact us by e-mail.